Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 4:34 AM
Study NCT ID:
NCT00691093
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526675', 'term': 'fesoterodine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'All Subjects', 'otherNumAtRisk': 823, 'otherNumAffected': 78, 'seriousNumAtRisk': 823, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 823, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 823, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 823, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 823, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 823, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.661', 'spread': '2.8565', 'groupId': 'OG000'}, {'value': '10.636', 'spread': '3.4269', 'groupId': 'OG001'}, {'value': '12.664', 'spread': '2.7612', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-2.306', 'spread': '1.5773', 'groupId': 'OG000'}, {'value': '-2.303', 'spread': '1.2863', 'groupId': 'OG001'}, {'value': '-1.566', 'spread': '1.4241', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-3.482', 'spread': '1.9022', 'groupId': 'OG000'}, {'value': '-2.848', 'spread': '1.1772', 'groupId': 'OG001'}, {'value': '-3.160', 'spread': '1.7571', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '-4.180', 'spread': '2.1018', 'groupId': 'OG000'}, {'value': '-4.000', 'spread': '1.2293', 'groupId': 'OG001'}, {'value': '-4.031', 'spread': '1.8995', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)', 'description': "Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.", 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.932', 'spread': '27.6079', 'groupId': 'OG000'}, {'value': '42.000', 'spread': '35.6059', 'groupId': 'OG001'}, {'value': '24.867', 'spread': '27.7108', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-6.650', 'spread': '16.4784', 'groupId': 'OG000'}, {'value': '-12.800', 'spread': '13.2313', 'groupId': 'OG001'}, {'value': '-2.364', 'spread': '11.2500', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-9.864', 'spread': '20.2348', 'groupId': 'OG000'}, {'value': '-18.700', 'spread': '22.2663', 'groupId': 'OG001'}, {'value': '-5.791', 'spread': '17.8493', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '-12.800', 'spread': '23.9575', 'groupId': 'OG000'}, {'value': '-21.000', 'spread': '24.3584', 'groupId': 'OG001'}, {'value': '-7.415', 'spread': '21.7658', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': 'The PVR urine volume: measured by an ultrasound scan.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation of Fesoterodine", 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Fesoterodine 4 or 8 mg'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '536', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3 or ET', 'description': "The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Evaluation of Fesoterodine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS'}, {'type': 'SECONDARY', 'title': 'Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.661', 'spread': '1.1663', 'groupId': 'OG000'}, {'value': '5.818', 'spread': '0.9816', 'groupId': 'OG001'}, {'value': '4.702', 'spread': '1.7925', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 or ET', 'description': "Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.263', 'spread': '17.5239', 'groupId': 'OG000'}, {'value': '70.000', 'spread': '10.1242', 'groupId': 'OG001'}, {'value': '64.737', 'spread': '17.1696', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '25.147', 'spread': '14.3690', 'groupId': 'OG000'}, {'value': '35.682', 'spread': '12.7520', 'groupId': 'OG001'}, {'value': '32.719', 'spread': '17.9115', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3 or ET', 'description': 'Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.027', 'spread': '1.2593', 'groupId': 'OG000'}, {'value': '4.000', 'spread': '1.4220', 'groupId': 'OG001'}, {'value': '3.528', 'spread': '1.3452', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-1.104', 'spread': '0.7960', 'groupId': 'OG000'}, {'value': '-1.212', 'spread': '0.8065', 'groupId': 'OG001'}, {'value': '-0.915', 'spread': '0.9115', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-1.621', 'spread': '0.9281', 'groupId': 'OG000'}, {'value': '-1.848', 'spread': '1.1290', 'groupId': 'OG001'}, {'value': '-1.613', 'spread': '1.0928', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '-1.914', 'spread': '1.0820', 'groupId': 'OG000'}, {'value': '-2.030', 'spread': '1.3035', 'groupId': 'OG001'}, {'value': '-2.072', 'spread': '1.0907', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': "Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.", 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.412', 'spread': '2.4355', 'groupId': 'OG000'}, {'value': '4.697', 'spread': '1.9914', 'groupId': 'OG001'}, {'value': '5.587', 'spread': '3.7759', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-1.890', 'spread': '1.5967', 'groupId': 'OG000'}, {'value': '-1.697', 'spread': '0.9827', 'groupId': 'OG001'}, {'value': '-1.650', 'spread': '1.3065', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-2.736', 'spread': '1.9249', 'groupId': 'OG000'}, {'value': '-2.182', 'spread': '1.4557', 'groupId': 'OG001'}, {'value': '-2.895', 'spread': '2.6468', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '-3.127', 'spread': '2.0210', 'groupId': 'OG000'}, {'value': '-2.636', 'spread': '1.7221', 'groupId': 'OG001'}, {'value': '-3.814', 'spread': '3.0690', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': "UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).", 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.601', 'spread': '1.7127', 'groupId': 'OG000'}, {'value': '2.933', 'spread': '1.2551', 'groupId': 'OG001'}, {'value': '3.467', 'spread': '2.4484', 'groupId': 'OG002'}]}]}, {'title': 'Visit 2 (Month 1)', 'categories': [{'measurements': [{'value': '-1.209', 'spread': '1.0891', 'groupId': 'OG000'}, {'value': '-1.067', 'spread': '1.1738', 'groupId': 'OG001'}, {'value': '-1.190', 'spread': '1.2532', 'groupId': 'OG002'}]}]}, {'title': 'Visit 3 (Month 2)', 'categories': [{'measurements': [{'value': '-1.806', 'spread': '1.3107', 'groupId': 'OG000'}, {'value': '-1.583', 'spread': '1.4974', 'groupId': 'OG001'}, {'value': '-1.781', 'spread': '1.4729', 'groupId': 'OG002'}]}]}, {'title': 'Visit 4 (Month 3 or ET)', 'categories': [{'measurements': [{'value': '-2.065', 'spread': '1.4582', 'groupId': 'OG000'}, {'value': '-1.733', 'spread': '1.6836', 'groupId': 'OG001'}, {'value': '-2.362', 'spread': '1.6477', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': 'The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Scores of OAB-q at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.101', 'spread': '16.0799', 'groupId': 'OG000'}, {'value': '-34.318', 'spread': '9.4928', 'groupId': 'OG001'}, {'value': '-32.018', 'spread': '17.7183', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3 or ET', 'description': 'Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Time To Onset Of Treatment Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine 4 mg'}, {'id': 'OG001', 'title': 'Fesoterodine 8 mg'}, {'id': 'OG002', 'title': 'Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.27', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.0', 'spread': '1.10', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3.0', 'spread': '2.72', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 1, Month 2, Month 3 or ET', 'description': "Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.", 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Study Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Fesoterodine 4 or 8 mg'}], 'classes': [{'title': 'Increased', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Stayed the same', 'categories': [{'measurements': [{'value': '766', 'groupId': 'OG000'}]}]}, {'title': 'Decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fluctuated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 or ET', 'description': 'Number of subjects that changed doses throughout the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS'}, {'type': 'SECONDARY', 'title': 'Reasons for Study Treatment Dose Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'Fesoterodine 4 mg or 8 mg'}], 'classes': [{'title': 'Inefectivity, Not Sufficient Effectivity', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Infectivity', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Insufficient (efficiency) effect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Insufficient response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Poor overall response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 or ET', 'description': 'Possible change in the dose and the reasons for the change were collected and documented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fesoterodine 4 mg or 8 mg', 'description': 'The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '823'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '816'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ongoing at Date of Cut-Off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fesoterodine 4 mg', 'description': 'The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}, {'title': '44-64', 'categories': [{'measurements': [{'value': '497', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '574', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '249', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 823}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2008-06-03', 'resultsFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-21', 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)', 'description': "Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit."}, {'measure': 'Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': "Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit."}, {'measure': 'Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': "UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit)."}, {'measure': 'Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': 'The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3 or ET', 'description': 'The PVR urine volume: measured by an ultrasound scan.'}, {'measure': "Patient's Global Evaluation of Fesoterodine", 'timeFrame': 'Baseline, Month 3 or ET', 'description': "The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'."}, {'measure': 'Clinical Global Evaluation of Fesoterodine', 'timeFrame': '12 weeks', 'description': "Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'"}, {'measure': 'Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4', 'timeFrame': 'Month 3 or ET', 'description': "Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given."}, {'measure': 'Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale', 'timeFrame': 'Baseline, Month 3 or ET', 'description': 'Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.'}, {'measure': 'Change From Baseline in Total Scores of OAB-q at Visit 4', 'timeFrame': 'Baseline, Month 3 or ET', 'description': 'Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=\\[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range\\] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.'}, {'measure': 'Time To Onset Of Treatment Response', 'timeFrame': 'Month 1, Month 2, Month 3 or ET', 'description': "Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment."}, {'measure': 'Study Doses', 'timeFrame': 'Month 3 or ET', 'description': 'Number of subjects that changed doses throughout the study period.'}, {'measure': 'Reasons for Study Treatment Dose Changes', 'timeFrame': 'Month 3 or ET', 'description': 'Possible change in the dose and the reasons for the change were collected and documented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['observational'], 'conditions': ['Overactive Bladder', 'Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.', 'detailedDescription': 'patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.\n* Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome\n* Due to intolerance: persistent and/or unacceptable adverse events\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to peanut or soya or any of the excipients.\n* History of acute urinary retention (requiring catheterisation)\n* Gastric retention\n* Uncontrolled narrow angle glaucoma\n* Myasthenia gravis\n* Severe hepatic impairment (Child Pugh C)\n* Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment\n* Severe ulcerative colitis\n* Toxic megacolon.'}, 'identificationModule': {'nctId': 'NCT00691093', 'briefTitle': 'Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.', 'orgStudyIdInfo': {'id': 'A0221059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 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